Suppliers and packagers for EDARBI

EDARBI

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-040-30	30 TABLET in 1 BOTTLE (60631-040-30)	2013-02-01
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-040-77	7 TABLET in 1 BOTTLE (60631-040-77)	2013-02-01
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-080-30	30 TABLET in 1 BOTTLE (60631-080-30)	2013-02-01
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796	NDA	Azurity Pharmaceuticals, Inc.	60631-080-77	7 TABLET in 1 BOTTLE (60631-080-77)	2013-02-01

Suppliers for the Pharmaceutical Drug: EDARBI

Last updated: July 30, 2025

Introduction

Edarbi (azilsartan medoxomil) is an angiotensin II receptor blocker (ARB) prescribed primarily for hypertension management. Developed by Takeda Pharmaceuticals, it offers an alternative for high blood pressure treatment with a distinctive profile, including high potency and a favorable side effect profile. As the pharmaceutical landscape evolves, understanding the supplier ecosystem for Edarbi becomes crucial for stakeholders—from healthcare providers to pharma companies and investors—seeking stability, quality, and supply chain resilience. This article explores current suppliers involved in producing Edarbi, their roles, and implications for the pharmaceutical market.

Edarbi’s Manufacturing and Supply Chain Overview

Takeda Pharmaceuticals is the originator and primary marketer of Edarbi. The drug’s active pharmaceutical ingredient (API), azilsartan medoxomil, is synthesized through complex chemical processes requiring specialized manufacturing facilities. These facilities are often operated by third-party API manufacturers under strict regulatory oversight (such as FDA or EMA standards) to ensure quality, safety, and efficacy.

While Takeda retains control over formulation, packaging, and distribution, the manufacturing of APIs often involves multiple subcontractors or licensors globally. The upstream supplier network includes raw material providers, intermediate manufacturers, and API producers—each vital for maintaining a steady supply for commercial distribution.

Key Suppliers in the Edarbi Supply Chain

1. Active Pharmaceutical Ingredient (API) Manufacturers

The cornerstone of Edarbi's supply chain is the API provider. The azilsartan medoxomil API’s complex synthesis involves multiple chemical steps necessitating high-quality intermediates and precision manufacturing.

• Takeda’s API Suppliers: Historically, Takeda has contracted multiple GMP-compliant API producers across Asia and Europe to mitigate supply risks and ensure scalability. While specific names are often confidential due to contractual restrictions, publicly available data note engagement with vendors in India, China, and Europe.

• Major API Producers:

  • China-based manufacturers: Several Chinese companies, such as Zhejiang Hisun Pharmaceutical Co., Ltd., and Zhejiang Huahai Pharmaceutical Co., Ltd., supply bulk ARB APIs, including analogs or intermediates related to azilsartan frameworks. Their involvement underscores China’s role as a global API hub.
  • Indian API manufacturers: Firms like Sun Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories have diversified portfolios that include ARBs, potentially serving as suppliers for azilsartan medoxomil APIs, either directly or through contract manufacturing.

• European API manufacturers: Specialists such as Synthesis Medchem BV and others in Europe focus on high-quality, regulation-compliant API synthesis, especially for markets demanding European GMP standards.

2. Raw Material Suppliers

The synthesis of azilsartan medoxomil demands specific chemical precursors and intermediates, often supplied by raw material vendors specializing in pharmaceutical-grade chemicals.

• Key raw chemicals include: tert-butyl carbamate derivatives, chlorinated aromatic compounds, and heterocyclic intermediates.
• Suppliers: Companies like Merck KGaA and Thermo Fisher Scientific provide pharmaceutical-grade chemicals used in API synthesis.

3. Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs)

Some pharmaceutical companies leverage CMOs/CDMOs to scale production or outsource specific synthesis steps due to capacity constraints or strategic focus.

• Notable players: Lonza, Patheon (downtowns in the U.S. and Europe), and Samsung Biologics may be involved in smaller-scale synthesis or formulation phases, though specific contracts for Edarbi are proprietary.

4. Formulation and Packaging

Takeda manages formulation, ensuring the API is correctly formulated into tablets, packaged, and labeled for global markets. Packaging suppliers include companies specializing in pharmaceutical blister packs and labeling compliant with regulatory standards.

Regulatory and Quality Standards

Suppliers involved in Edarbi’s production must adhere to stringent Good Manufacturing Practice (GMP) guidelines. Takeda’s supply chain partners undergo rigorous audits and compliance checks by regulatory agencies to guarantee consistency, safety, and efficacy.

Supply Chain Challenges and Risks

• Procurement dependencies: Heavy reliance on Asian API manufacturers exposes supply chains to geopolitical and manufacturing risks, including regulatory changes, trade restrictions, and capacity constraints.
• Raw material volatility: Fluctuations in the availability or price of critical chemical precursors, driven by global supply-demand mismatches, can impact production.
• Regulatory compliance: Variations in manufacturing standards across global suppliers may lead to quality discrepancies, affecting approval status and market access.

Market Dynamics and Supplier Relations

Takeda’s strategic engagement with diversified suppliers aims to mitigate supply disruptions. The company maintains long-term contracts with multiple vendors, emphasizing compliance and quality assurance. Recent market trends favoring consolidation and increased oversight are influencing supplier relationships in the ARB manufacturing domain.

Conclusion

The supply chain for Edarbi involves a complex network of specialized API manufacturers primarily located in China, India, and Europe. These suppliers provide the high-quality ingredients essential for maintaining the drug’s efficacy and regulatory approval. As the pharmaceutical industry grapples with supply chain resilience challenges, stakeholders must prioritize supplier diversification, quality assurance, and proactive risk management to ensure steady access to Edarbi.

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Key Takeaways

• The primary API for Edarbi is synthesized by global manufacturers, with significant contributions from suppliers in China, India, and Europe.
• Contract manufacturing organizations play a vital role in scaling production and ensuring quality standards.
• Demand for raw materials and active pharmaceutical ingredients (APIs) impacts overall supply chain stability.
• Regulatory compliance and quality assurance are critical in maintaining Edarbi’s market presence and efficacy.
• Stakeholders should monitor geopolitical, logistical, and regulatory shifts impacting supplier networks to mitigate risks.

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FAQs

1. Who are the main API suppliers for Edarbi?
While Takeda primarily sources azilsartan medoxomil API from suppliers across China, India, and Europe, specific vendor identities often remain confidential due to contractual agreements. Key players include Chinese and Indian pharmaceutical manufacturers with GMP compliance.

2. Are there alternative suppliers for Edarbi’s API?
Takeda likely maintains multiple supplier relationships to ensure supply continuity, with ongoing efforts to identify and qualify additional vendors to prevent disruptions.

3. What challenges does the Edarbi supply chain face?
Major challenges include geopolitical tensions, raw material shortages, regulatory discrepancies across regions, and capacity limitations, all of which can impact production timelines.

4. How does Takeda ensure quality in its supply chain?
Takeda conducts rigorous audits, enforces GMP standards, and maintains strict supplier qualification processes to uphold consistent quality and regulatory compliance.

5. Is there potential for generic versions of Edarbi to impact its supply chain?
Yes. The patent expiration of angiotensin receptor blockers often leads to the emergence of generics, which can influence supply dynamics, pricing, and competition in the market. Suppliers for generics may differ, impacting the overall API sourcing landscape.

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Sources:
[1] Takeda Pharmaceuticals — Official Website.
[2] Global Pharmaceutical API Market Reports (2022).
[3] FDA Database on API Manufacturers.
[4] Industry publications on ARB manufacturing and supply chain.